3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specif
FDA device recall Z-0492-2026 · posted 2025-11-13 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
- Action taken
- On October 6, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions Perform the instructions provided below: " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Discontinue use of and discard IMMULITE 2000 Oak Mix Specific Allergen Lot 627. " Review your inventory of the product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution The issue is resolved with the next available lot of IMMULITE 2000 Oak Mix Specific Allergen. It is anticipated that the replacement lot will be available by mid-November 2025. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Custom
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DHB
- Quantity affected
- 2802 units (OUS only)
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cz
- Date initiated
- 2025-10-06
- Date posted
- 2025-11-13
- Location
- East Walpole, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K101572) | Siemens Healthcare Diagnostics | 2011-08-01 |